1.Research progress in antibody drug therapy for relapsed/refractory diffuse large B-cell lymphoma
Yanyan SUN ; Weichen ZHAO ; Chunyuan HE ; Yimiao XIA ; Wei ZHOU ; Yuanyuan ZHEN ; Junjie JIANG ; Facai WANG
China Pharmacy 2025;36(13):1677-1682
Diffuse large B-cell lymphoma (DLBCL) is a highly heterogeneous disease. Although standard first-line regimens can cure >50% of patients, approximately one-third of them develop relapsed/refractory DLBCL (r/r DLBCL). Consequently, immunotherapy targeting molecular abnormalities has become pivotal for managing r/r DLBCL. The results of this review show that with advances in understanding DLBCL pathogenesis and the tumor immune microenvironment, antibody-based therapies have evolved rapidly, progressing from monoclonal antibodies (e.g., rituximab, tafasitamab) to bispecific antibodies(e.g., odronextamab,glofitamab, epcoritamab) and antibody-drug conjugate (e.g., polatuzumab vedotin, loncastuximab tesirine). These engineered agents enhance immune cytotoxicity and tumor-specific targeting, providing novel therapeutic options for r/r DLBCL patients.
2.Development and application of core competency evaluation index system for ethics committee members of drug clinical trial institution
Xiaohua TANG ; Qingqing JIANG ; Haiwei ZHANG ; Weiran MAO ; Yuanyuan YIN ; Jiangdong SUI ; Jun LI ; Xia CHEN
China Pharmacy 2025;36(20):2489-2494
OBJECTIVE To construct an evaluation index system for the core competencies of ethics committee members of drug clinical trial institution, providing a basis for optimizing the training system for committee members, improving the quality of ethical review, and fully safeguarding the safety and rights of subjects. METHODS Using methods such as literature research and expert consultation, a preliminary core competency evaluation index system was constructed. The Delphi method was employed to revise and validate it, ultimately forming an evaluation index system for the core competencies of ethics committee members. Based on this system, a questionnaire survey was conducted among 90 ethics committee members from 29 drug clinical trial institutions nationwide, comparing their importance rating and self-assessment scores of the core competency indexes. RESULTS The evaluation system constructed included 4 primary indicators (ethics and professional knowledge, ethics review ability, communication and expression ability, moral integrity and work style) and 39 secondary indicators (familiarity with the content of clinical trial-related laws and regulations, ability to complete project ethics review and identify ethical defects in research protocols within a short period of time, ability to judge the scientific value of clinical research, etc.). The results of questionnaire survey showed that the interviewed ethics committee members had significant capability gaps in dimensions such as regulatory knowledge, ethical norms, review efficiency, risk judgment, and problem analysis. The differences between the importance rating scores of corresponding secondary indicators and the self-assessment scores were all no less than 0.38. CONCLUSIONS This study has developed a quantifiable and stratified core competency assessment tool for ethics committee members. It can provide a scientific framework for committee member training, qualification certification, and standardized management of ethics committees.
3.Teaching practice of the problem-based hands-on inquiry-based comprehensive experiment of blood-borne protozoa infections and diagnosis
Xia ZHOU ; Yuanyuan LI ; Yan HE ; Lei WANG
Chinese Journal of Schistosomiasis Control 2025;37(5):537-541
Cultivating and inspiring students’ interests in performing experiments and improving students’ diagnostic skills and scientific research capability for infectious diseases like malaria are critical to comprehensive experimental teaching of morphology. Consequently, Soochow University initiated a problem-based hands-on inquiry-based comprehensive experiment program of blood-borne protozoa infections and diagnosis, which took students in the “5 + 3” integrated program of clinical medicine as the teaching targets, and it consisted of three parts: pre-class, in-class, and post-class. Before the experimental curriculum, students learned the theoretical knowledge and the process of modeling Plasmodium berghei and Babesia microti infections in mice through online course and virtual simulation experiments, and during the experimental curriculum, students performed exploratory experiments on differential diagnosis of P. berghei and B. microti infections with pathogenic and serological tests. After the experimental curriculum, students performed molecular biological testing and extracurricular scientific research project training through open experiments. A questionnaire survey was conducted among 99 students in the “5 + 3” integrated training program of clinical medicine in batch 2021, and a total of 93 valid questionnaires were retrieved, with a questionnaire recovery rate of 93.94%. Questionnaire survey showed that 70.97% (66/93), 70.97% (66/93), 77.42% (72/93), 70.97% (66/93), and 83.87% (78/ 93) of the students strongly agreed with the five statements in the questionnaire respectively, namely “high interest in learning during the experiment”, “reasonable experimental content settings and good classroom atmosphere”;, “teachers were good at guiding students’ practice and thinking”, “students were the main body of the classroom during the experiment” and “Comprehensive experiments had better teaching effects than traditional verification experiments”, indicating that the problem-based hands-on inquiry-based comprehensive experiment teaching has enhanced students’ learning interest, spirit of inquiry, innovative thinking, and teamwork ability.
4.Development and application of core competence assessment index system among drug clinical trial quality control personnel
Yu CHEN ; Qingqing JIANG ; Guo YE ; Weiran MAO ; Yuanyuan YIN ; Mengjuan ZHANG ; Pu SUN ; Xia CHEN
China Pharmacy 2025;36(24):3023-3028
OBJECTIVE To establish a core competency evaluation system for drug clinical trial quality management personnel in China and validate its application. METHODS Based on the scope of work, responsibilities, and role positioning of quality management personnel in drug clinical trials, a preliminary draft of the core competency evaluation system was constructed through literature analysis and expert consultation. The draft was refined through a Delphi method involving 17 experts who provided feedback and revisions, ultimately forming a complete evaluation system. The developed system was applied to conduct electronic surveys from March to May 2024 among 110 quality management personnel from 38 drug clinical trial institutions, comparing their scores on indicator importance and self-assessed capabilities. RESULTS The response rate of both rounds of questionnaire survey was 100%, with Kendall’s W coefficients of 0.256 and 0.277 (P<0.001 for both), and an expert authority coefficient of 0.946. The finalized evaluation system for core competencies of clinical trial quality management personnel comprised 9 primary indicators, covering individual professional competence, communication skills, implementation condition verification, informed consent process review, clinical trial execution monitoring, adverse event disposal, reporting and documentation, trial record examination, trial report auditing, and inspection of other tasks, and 107 secondary indicators. Empirical research revealed significant discrepancies between importance scores and self-assessed competency scores across 70 indicators among 110 respondents (P<0.05). Indicators with relatively notable gaps between importance scores and self-assessed competency scores included in-depth understanding of Good Clinical Practice (GCP) requirements (0.34-point gap), familiarity with national and institutional clinical trial inspection priorities (0.24-point gap),etc. CONCLUSIONS The indicator system constructed in this study has good scientificity and reliability. Clinical trial quality management personnel demonstrate deficiencies in multiple critical competencies, highlighting the urgent need for targeted training programs to enhance their overall professional capabilities.
5.Discussion on the Treatment of Heart Failure from the Theory of "Sweat Pore-Collaterals-Zang and Fu Organs" Based on Mitochondrial Function
Yuxuan LI ; Wujiao WANG ; Peng LI ; Yuanyuan ZHANG ; Xingxing LI ; Junyan XIA ; Ruli FENG ; Dong LI ; Qian LIN ; Yan LI
Journal of Traditional Chinese Medicine 2024;65(13):1346-1352
Mitochondria are the main site of energy metabolism in cardiomyocytes, and at the same time mediate apoptosis and immune response, so mitochondrial dysfunction is closely related to the development of heart failure. Combined with the pathogenesis of mitochondrial dysfunction and heart failure, it is proposed that the mitochondrial function is similar to "sweat pore - collaterals - zang and fu organs", according to which the treatment of heart failure is based on the theory of "sweat pore - collaterals - zang and fu organs". It is believed that the core mechanism of heart failure is qi deficiency, and qi deficiency leads to the weakness of the sweat pore opening and closing, or even the sweat pore closure, then resulting in qi deficiency and blood stasis, collaterals stagnation fail to flourish, and qi, blood, and body fluids can not infiltrate and nourish zang-fu organs, so that the heart fail to be nourished, and the disease will develop. The treatment should be based on the method of boosting qi and opening sweat pore, using acridity to unblock the collaterals, and invigorating blood and draining water, with medicinal of boosting qi, invigorating blood, and draining water as treatment.
6.Association between preschoolers physical activity levels and parental sports concept and behavior
Chinese Journal of School Health 2024;45(7):1036-1039
Objective:
To analyze the impact of parental sports concept and behavior on physical activity in preschool children, so as to provide a foundation for future guidance on fostering childrens physical activity within the family context.
Methods:
From November to December 2020, a clustered convenience sampling method was employed to conduct surveys, and a total of 283 children were selectal from one kindergarten each in Beijing, Shenyang, and Xian. Participating children wore ActiGraph GT9X accelerometers continuously for one week to collect data on different intensity levels of physical activity. Physical Activity afterschool Questionnaire for Preschooler (P-PAQ) was utilized to assess parental sports concept and behavior. The gender differences in physical activity level and physical activity compliance rate were analyzed by using ttest, Mann-Whitney U test, and Chisquare test; and the relationship between parental exercise concepts and behaviors and physical activity of preschool children was analyzed using Spearman rank correlation analysis and multiple linear regression analysis.
Results:
Parental sports concept was significantly positively correlated with average daily moderatetovigorous physical activity (MVPA) and total physical activity (TPA) in children (r=0.12-0.16, P<0.05). Parental sports behavior was significantly positively correlated with childrens average daily TPA (r=0.25, P<0.05). Multiple linear regression revealed that parental sports concept was positively correlated with average daily MVPA and TPA in both boys and girls (B=0.65-0.83), while parental sports behavior only was positively correlated with boys average daily MVPA and TPA (B=0.24-0.25)(P<0.05).
Conclusions
Parental sports concept and behavior can impact physical activity levels in preschool children, exhibiting gender differences. Future guidance on physical activity in family upbringing should consider both parental sports concept and behavior, and pay attention to the influence of childrens gender.
7.Investigation of occupational health of nuclear medicine radiation workers in Jiangsu Province, China, 2023
Wei CHEN ; Shihao WU ; Xindi WEI ; Xiangyong FAN ; Yuanyuan ZHOU ; Yuji MIAO ; Yeqing GU ; Jinhan WANG ; Zhili XIA ; Zihao ZHANG ; Jin WANG
Chinese Journal of Radiological Health 2024;33(5):542-548
Objective To investigate the basic situation and occupational health conditions of nuclear medicine radiation workers in Jiangsu Province based on the research protocol developed by the Institute of Radiation Medicine, Chinese Academy of Medical Sciences for the nationwide study on the health effects of nuclear medicine radiation in China, understand the impact of occupational radiation on the physical health of nuclear medicine radiation workers, and provide a basis for improving the occupational protection of nuclear medicine radiation workers and reducing the risk of occupational radiation-related health issues. Methods A census approach was used to collect general data and occupational health information of nuclear medicine radiation workers in Jiangsu Province. The analysis focused on the abnormalities in physical examination indicators among radiation workers of different genders, ages, and working years to evaluate the health effects of occupational radiation exposure. Results The occupational health examination data of 472 nuclear medicine radiation workers were collected from 76 medical institutions in Jiangsu Province. The results showed that the detection rate of abnormal hypothyroidism in female workers (8.90%) was higher than that in male workers (2.54%) (P=0.028). With increasing working years, the detection rates of cataract and continuous decrease in white blood cell count increased (P<0.001). The multivariate logistic regression identified working years as a risk factor for cataract and continuous decrease in white blood cell count (OR=1.59, 95%CI=1.40-3.35, P=
8.Investigation of occupational health of nuclear medicine radiation workers in Jiangsu Province, China, 2023
Wei CHEN ; Shihao WU ; Xindi WEI ; Xiangyong FAN ; Yuanyuan ZHOU ; Yuji MIAO ; Yeqing GU ; Jinhan WANG ; Zhili XIA ; Zihao ZHANG ; Jin WANG
Chinese Journal of Radiological Health 2024;33(5):542-548
Objective To investigate the basic situation and occupational health conditions of nuclear medicine radiation workers in Jiangsu Province based on the research protocol developed by the Institute of Radiation Medicine, Chinese Academy of Medical Sciences for the nationwide study on the health effects of nuclear medicine radiation in China, understand the impact of occupational radiation on the physical health of nuclear medicine radiation workers, and provide a basis for improving the occupational protection of nuclear medicine radiation workers and reducing the risk of occupational radiation-related health issues. Methods A census approach was used to collect general data and occupational health information of nuclear medicine radiation workers in Jiangsu Province. The analysis focused on the abnormalities in physical examination indicators among radiation workers of different genders, ages, and working years to evaluate the health effects of occupational radiation exposure. Results The occupational health examination data of 472 nuclear medicine radiation workers were collected from 76 medical institutions in Jiangsu Province. The results showed that the detection rate of abnormal hypothyroidism in female workers (8.90%) was higher than that in male workers (2.54%) (P=0.028). With increasing working years, the detection rates of cataract and continuous decrease in white blood cell count increased (P<0.001). The multivariate logistic regression identified working years as a risk factor for cataract and continuous decrease in white blood cell count (OR=1.59, 95%CI=1.40-3.35, P=
9.Exploring the Effect of Medication-Containing Serum of Pingwei Capsules (平胃胶囊) on MNNG-Induced Inflammatory Cancer Transformation of Human Gastric Mucosal Epithelial Cells Based on Raf/MEK/ERK Pathway
Xia WANG ; Lijuan WANG ; Xiaoying NIU ; Zekun FAN ; Yuanyuan NIU ; Lanfang MAO ; Longde WANG
Journal of Traditional Chinese Medicine 2024;65(10):1056-1062
ObjectiveTo explore the possible mechanism of Pingwei Capsules (平胃胶囊) for chronic atrophic gastritis from rapidly accelerated fibrosarcoma / mitogen-activated protein kinase /extracellular-signal-regulated kinase (Raf/MEK/ERK) pathway that influences the activation of fibrosarcoma protein/mitogen. MethodsFifteen SD rats were randomly divided into 5 rats in the blank group and 10 rats in Pingwei Capsules group. The rats in the blank group were given 1 ml/100 g of saline by gavage, and the rats in Pingwei Capsules group were given 0.63 g/(kg·d) of Pingwei Capsule suspension by gavage, and serum was collected for 3 consecutive days. N-methyl-N'-nitro-N-nitrosoguanidine (MNNG) was used to induce human gastric mucosal epithelial cells GES-1 to establish a precancerous lesion cell model. The successful cells were divided into control group (10% fetal bovine serum), blank serum group (10% fetal bovine serum plus 10% blank serum), and medication-containing serum group (serum with medication of Pingwei Capsule), and the volume fraction and time of intervention of Pingwei Capsule-containing serum were screened by CCK-8 assay. Human gastric mucosal epithelial cells GES-1 were divided into normal group, model group, blank serum group, medication-containing serum group, U0126 group, and combined group, with 6 replicate wells in each group. After successful modelling of the cells in all groups except the blank group, an equal volume of fetal bovine serum was added to the normal and model groups, an equal volume of blank serum was added to the blank serum group, a screening volume fraction of Pingwei Capsule-containing serum was added to Pingwei Capsule group, a 10 μmol/L mitogen-activated extracellular signal regulated kinase 1 (MEK1) inhibitor U0126 was administered in the U0126 group, an equal dose of Pingwei Capsule-containing serum plus 10 μmol/L of U0126 was administered to the combined group. After the selected incubation time, the level of interleukin 6 (IL-6) was detected in the cells by ELISA, the expression of IL-6 and MEK1 was detected by immunofluorescence, and the expression of IL-6, Raf, MEK1, and ERK mRNA was detected by RT-qPCR, and the expression of IL-6, Raf, MEK1, and ERK mRNA in the cells was detected by Western blot. ResultsThe 5.35% volume fraction, 48 h intervention of Pingwei Capsule-containing serum was selected for subsequent experiments. Compared with the normal group, the IL-6 content in cell supernatants and the expression of IL-6, Raf, MEK1, ERK mRNA and ERK1/2 proteins in cells increased in the model group and blank serum group (P<0.01). Compared with the model group, all of the above indexes were improved in medication-containing serum group, U0126 group, and combined group (P<0.05 or P<0.01). Compared with medication-containing serum group, the expression of IL-6, MEK1 expression, the expression of IL-6, Raf, MEK1 and ERK mRNA, and the expression of IL-6, Raf, MEK1 and ERK1/2 proteins reduced in the cells of combined group (P<0.05 or P<0.01). Compared with the U0126 group, IL-6 expression reduced and IL-6, MEK1 and ERK1/2 protein expression reduced in cells of combined group (P<0.05 or P<0.01). ConclusionThe Pingwei Capsule-containing serum may play a role in the treatment of chronic atrophic gastritis by improving the inflammation-cancer transformation of GES-1 cells through inhibiting the Raf/MEK/ERK pathway.
10.Effect and its mechanism of esketamine on anxiety and depression in mice
Jingwen Zhou ; Yuanhai Li ; Gaolin Qiu ; Wen Cai ; Yuanyuan Zhao ; Xiaoqiong Xia
Acta Universitatis Medicinalis Anhui 2024;59(1):106-110
Objective :
To explore the effect of esketamine on anxiety-depressive-like behavior in mice and its rela- tionship with inflammation.
Methods :
SPF grade healthy adult male C57BL/6J mice,weighing 20 -24 g,were used in the exprement.The random number table method was used to divide into 5 groups (n = 8) : control group ( Con group) ,esketamine group (ESK group) ,model group ( LPS group) ,model + esketamine prevention group (LPS + ESK1 group) and model + esketamine treatment group ( LPS + ESK2 group) .An inflammation-induced anxiety-depression model was prepared by intraperitoneal injection of LPS 0. 83 mg / kg.The ESK group was injec- ted with esketamine 10 mg / kg ; LPS group was injected with LPS 0. 83 mg / kg ; LPS + ESK1 group was injected with LPS 0. 83 mg / kg before 24 hours intraperitoneal injection of esketamine 10 mg / kg ; and the LPS + ESK2 group was injected with LPS 0. 83 mg / kg and 30 minutes later with esketamine 10 mg / kg.24 h after intraperitoneal injec- tion of LPS,the anxiety-depression-like behaviors of mice were measured using behavioral experiments.At the end of behavioral experiments,the spleen was taken immediately ; hippocampal tissues were taken and enzyme-linked immunosorbent assay (ELISA) was used to detect the contents of interleukin-1 β (IL-1 β) ,tumor necrosis factor al- pha (TNF-α) and interleukin 6 (IL-6) and neuronal pathological changes in hippocampal tissues were observed by HE staining.
Results :
Compared with the Con group,mice in the LPS group showed increased anxiety and depres- sion-like behavior (P<0. 05) ,increased spleen weight / body weight (P <0. 05 ) ,increased hippocampal tissue concentrations of IL-1 β , TNF-α and IL-6 (P<0. 05) ,and increased neuronal degeneration necrosis,there was no statistically significant difference in these indicators in the ESK group compared with the Con group.Compared with the LPS group,mice in the LPS + ESK1 and LPS + ESK2 groups showed reduced anxiety-depression-like behavior (P<0. 05) ,decreased splenic weight / body weight (P <0. 05) ,hippocampal tissue IL-1 β , TNF-α , IL- 6 con- centrations were reduced (P<0. 05) ,and neuronal degeneration necrosis was reduced.Compared with the LPS + ESK1 group,the LPS + ESK2 group showed an increase in the distance travelled in the central area of the open field experiment and the distance into the open arm of the elevated cross maze experiment (P<0. 05) ,a decrease in IL-6 and TNF-α concentrations (P<0. 05) ,and a reduction in the degree of neuronal damage.
Conclusion
Esketamine ameliorates LPS-induced anxiety-depression-like behavior and neuronal damage in mice by a mechanism that may be related to reduced inflammation.


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